[Reporting ethics board approval in German medical theses and journals]. / Erwähnung des Ethikvotums in deutschen medizinischen Dissertationen und Publikationen.

Since 1975, the Declaration of Helsinki of the World Medical Association (WMA) has clearly required ethics committee approval for research into humans. Nevertheless, this Declaration is violated quite often. As many English-language publications have addressed the theme of ethics board approval in theses and other published works, it is now to be investigated in Germany for the first time.From 2013 to 2014, a total of 1,482 medical theses at four selected universities in addition to three German-language scientific journals were reviewed. In 543 theses, reference to ethics approval would have been required according to the criteria of the Declaration of Helsinki.However, ethics approval was stated in only 58.7% of cases, and even less frequently if the prevailing doctoral regulations or instructions did not refer to the necessity of obtaining ethics approval. Theses on pediatrics mentioned ethics approval most frequently (78.6%), whereas the proportion of surgical papers was the lowest (34.9%). Among the journals, Der Nervenarzt mentioned ethics approval most frequently (59.4%) and Der Chirurg least frequently (30%).Our results point to significant deficits in mentioning ethics approval in medical theses and publications. These deficits could easily be compensated for by a thorough approach of the referees of doctoral regulations and by journal reviewers and editors.

[Physician Assisted Suicide - Survey on § 217 StGB in Germany]. / Ärztlich assistierter Suizid ­ Umfrage zu § 217 StGB.

Background In late 2015, Germany passed a law (§â€Š217 StGB) prohibiting persons from aiding others in committing suicide on a regular, repetitive basis. Despite intensive societal debate and surveys about assisted dying, the present study was the first to examine attitudes towards the new legal regulation among professionals. Methods In early 2016, all participants of a congress on palliative care received a one-page anonymous questionnaire to complete until the end of the conference. The questionnaire consisted of questions regarding assisted suicide and the new law. The participants were asked to express their agreement or disagreement on a 4 to 5-point Likert scale. Results 457 questionnaires (48 %) were completed, 138 from physicians, 318 from nurses, 1 non specified. More than 80 % knew about the new law. Only half of the respondents supported it. 54 % felt that the law did not sufficiently differentiate between an illegal form of assisted suicide and a form exempt from prosecution. For more than 40 % the new law made no sense. Conclusion Professionals engaged in terminal care were reluctant to support a criminal liability of "business-like" physician-assisted suicide and suspected greater uncertainty among professionals in end of life care.

Survey on German Palliative Care Specialists' Experiences with Advance Directives.

INTRODUCTION: Advance directives (AD) play a central role in end-of-life treatments, intensive care, and palliative care. However, little is known about the experiences of healthcare professionals with ADs. This study reports on palliative care professionals' views on advance directives (AD). METHODS: A questionnaire was handed out to attendants of a palliative care symposium. RESULTS: Complete answers were obtained from 126 physicians and 276 nurses. Almost all physicians and nurses had treated patients with an AD, and the majority more than 10 patients. The most frequent refusal by the patients was resuscitation (87.8%) followed by intensive care (79.1%), artificial ventilation, and nutrition. The most frequent wish was pain therapy (92.3%) followed by allowing the natural course of the illness (64.4%). The wish for hospice treatment (44.8%) or spiritual care (39.3%) was less frequent. DISCUSSION: The results hint at fears and deficits in the care of patients at the end of life. Often the quality of life and not the quantity of days remaining is in the center of a patient's will and points to the growing importance of palliative care. CONCLUSION: ADs are well established among palliative care professionals and regarded as helpful for patients at the end of life.

Palliative care professionals' willingness to perform euthanasia or physician assisted suicide.

BACKGROUND: Euthanasia and physician assisted suicide (PAS) are highly debated upon particularly in the light of medical advancement and an aging society. Little is known about the professionals' willingness to perform these practices particularly among those engaged in the field of palliative care and pain management. Thus a study was performed among those professionals. METHODS: An anonymous questionnaire was handed out to all participants of a palliative care congress and a pain symposium in 2013. The questionnaire consisted of 8 questions regarding end of life decisions. Proposed patient vignettes were used. RESULTS: A total of 470 eligible questionnaires were returned, 198 by physicians, 272 by nurses. The response rate was 64 %. The majority of professionals were reluctant to perform euthanasia or PAS: 5.3 % of the respondents would be willing to perform euthanasia on a patient with a terminal illness if asked to do so. The reluctance grew in case of a patient with a non-terminal illness. The respondents were more willing to perform PAS than euthanasia. Nurses were more reluctant to take action as opposed to the physicians. The majority of the respondents would attempt to treat the patient's symptoms first before considering life-ending measures. As regards any decision making process the majority would consult with a colleague. CONCLUSIONS: This is the first German study to ask about the willingness of professionals to take action as regards euthanasia and PAS without biased phrasing. As opposed to the general acceptance that is respectively high, the actual willingness to perform life-ending measures is low. The German debate on physician assisted suicide and its possible legalization should also incorporate clarifications regarding the responsibility who should eventually perform these acts.

Physician-Assisted Dying: Acceptance by Physicians Only for Patients Close to Death.

This study reports on German physicians' views on legalization of euthanasia and physician-assisted suicide, comparing this with a similar survey of UK doctors. A questionnaire was handed out to attendants of a palliative care and a pain symposium. Complete answers were obtained from 137 physicians. Similar to the UK study, about 30% of the physicians surveyed support euthanasia in case of terminal illness and more support physician-assisted suicide. In contrast, in both countries, a great majority of physicians oppose medical involvement in hastening death in non-terminal illnesses. The public and parliamentary discussion should face this opposition to assisted suicide by pain and palliative specialists.

Low pain intensity after opioid withdrawal as a first step of a comprehensive pain rehabilitation program predicts long-term nonuse of opioids in chronic noncancer pain.

OBJECTIVES: In specialized pain clinics there is an increasing number of patients with severe chronic noncancer pain (CNCP) despite long-term opioid medication. Few clinical studies show short-term pain relief after opioid withdrawal (OW). We have evaluated the relation between pain intensity after OW and long-term opioid nonuse. METHODS: One hundred two consecutive patients with severe CNCP despite opioid medication (mean treatment duration, 43 mo) reported pain intensity (numerical rating scale, 0 to 10), Pain Disability Index, mood (CES-D), and quality of life (Short Form 36) before, shortly, and 12 to 24 months after inpatient OW. Total opioid withdrawal (n = 78) or significant dose reduction (DR; n = 24, mean reduction, 82%) was performed after individual decision. Opioid intake 12 to 24 months later, respectively dose increase ≥ 100% (DR group), was considered relapse. T tests, multivariable analysis of variance, logistic regression. RESULTS: After OW current pain intensity significantly decreased on an average by 41% (6.4 ± 2.4 vs. 3.8 ± 2.5), maximal and average pain by 18% and 24%, respectively. Twelve to 24 months later 42 patients (41%) relapsed (31 of the total opioid withdrawal group, 6 of the DR group, 5 lost). Patients without later relapse showed significantly lower pain scores than the later relapsed patients already shortly after OW (5.0 ± 2.2 vs. 5.9 ± 2.1) and 12 to 24 months later (5.5 ± 2.4 vs. 6.5 ± 2.0). There was a significant relation between relapse probability and pain intensity immediately after OW. CONCLUSIONS: In many patients with severe CNCP, despite opioid medication, sustainable pain relief can be achieved if OW is included in the rehabilitation program. Consequently, we recommend OW for opioid-resistant CNCP before any opioid escalation. Lower pain intensity shortly after OW may predict the long-term opioid nonuse probability.

Are sympathetic blocks useful for diagnostic purposes?

BACKGROUND: Sympathetically maintained pain (SMP) can occur in patients with neuropathic pain. Sympathetically maintained pain is frequently diagnosed clinically by assessing the analgesic effect of an appropriate sympathetic block (SB). The diagnostic value of such blocks depends on both the degree of sympathetic activity disruption achieved and its duration without unintentional concomitant sensory block. METHODS: This pilot study evaluated the rate of diagnostically valuable SBs performed by experienced anesthesiologists in 19 patients (stellate/thoracic blocks: n = 11, lumbar blocks: n = 12). Monitoring included pain rating before SB; 10 and 30 minutes; and at 1, 3, and 6 hours after SB; bilateral skin temperature 30 minutes before SB through 120 minutes after SB; and detection of bilateral thresholds for cold, warmth, tactile, and vibration stimuli before and after. RESULTS: Ten (43%) of 23 SBs were not eligible for SMP diagnosis (4 had insufficient skin temperature increase; and 6 had cold or tactile detection threshold increases in the painful area). In 11 of the SBs, no significant sensory threshold change was detected; however, 2 individuals demonstrated marked reductions in the cold or tactile sensory thresholds. Sympathetically maintained pain was diagnosed in 3 (25%) of the 12 patients who had at least 1 SB with the required skin temperature increase without concomitant somatosensory block. CONCLUSIONS: Sympathetic blocks are useful in the diagnosis of SMP. However, their value is limited by the potential for false positives (unintentional sensory block) or false negatives (insufficient SB). Adequate monitoring of the sympathetic and somatosensory function for a minimum of 90 minutes after the intervention is essential to ensure that a valid diagnosis of SMP is made.

Is anesthesia dangerous?

BACKGROUND: Recent years have seen a rise in overall anesthesia-related mortality. METHOD: Selective review of the literature. RESULTS: Anesthesia-related mortality has fallen from 6.4/10 000 in the 1940s to 0.4/100 000 at present, largely because of the introduction of safety standards and improved training. The current figure of 0.4/100 000 applies to patients without major systemic disease; mortality is higher among patients with severe accompanying illnesses, yet in this group, too, perioperative mortality can be reduced by appropriate anesthetic management. Moreover, the use of regional anesthesia can also improve the outcome of major surgery. CONCLUSION: A recent increase in the percentage of older and multimorbid patients among persons undergoing surgery, along with the advent of newer types of operation that would have been unthinkable in the past, has led to an apparent rise in anesthesia-associated mortality, even though the quality of anesthesiological care is no worse now than in the past. On the contrary, in recent years, better anesthetic management has evidently played an important role in improving surgical outcomes.

Relationship of the internal jugular vein to the common carotid artery: implications for ultrasound-guided vascular access.

BACKGROUND AND OBJECTIVE: For cannulation of the internal jugular vein (IJV), ultrasound increases the number of first pass successes and reduces the rate of mechanical complications. A frequent complication of IJV access is the accidental injury of the common carotid artery (CCA), which can be dangerous in some circumstances. Landmarks and palpation of the CCA are used when ultrasound is not available. These conventional methods are based on the lateral position of the IJV to the CCA, and physicians traditionally employ head rotation to increase the success rates of IJV cannulation. Ultrasound scanning strictly from the anterior to posterior is not possible for this process because the probe must be adequately coupled to compensate for the curvature of the neck. Scans have been performed from different angles lateral to the neck, but misleadingly depict the relationship of the IJV to the CCA. In this study, the authors examined the effect of scanning at a 45° angle at the level of the cricoid on the depiction of the IJV in relation to the CCA. Furthermore, the influence of 30° head rotation to the contralateral side was also investigated. METHOD: The relationship of the IJV to the CCA was recorded using ultrasound in 600 patients. Patients were placed in a supine position and the probe was coupled at the level of the cricoid, scanning at an angle of 45° from the lateral side of the neck. Based on the ultrasound images, the position of the IJV in relation to the CCA was recorded using a segmented grid. The centre of the vein (cross-section of the vertical and longitudinal diameter) determined the segment classification, in which the top of the ultrasound image was defined as the anterior. Additionally, in 300 patients, the head was rotated to the contralateral side at 30° to examine the impact of head rotation on the position of the IJV. RESULTS: The IJV was found in the lateral segment in only 3.0-3.3% of the patients. It was found in the anteromedial segment more frequently on the left side compared to the right side (P < 0.005). On the right side, the IJV was shown more frequently in the anterolateral position (P < 0.0001). Head rotation at 30° in 300 of the 600 patients caused a significant change of the IJV position in the left anteromedial segment, in that it frequently placed the IJV towards the anterior and anterolateral segment (P < 0.05). There was no significant impact of head rotation on the IJV representation on the right side. Atypical positions of the IJV (posterior, medial or thrombosis) were found in some cases. CONCLUSION: Ultrasound images used for IJV access usually depict the vein as being anterior to the CCA and only to a minor extent in the lateral position. This positioning is important for needle processing in order to avoid accidental arterial puncture and to identify atypical positions of the IJV. To determine the ideal puncture site, images of the neck vessels along their entire pathway should be obtained when using ultrasound for vascular access.

The quality of pain management in German hospitals.

BACKGROUND: The Pain-Free Hospital Project was initiated in 2003 with the aim of improving pain management throughout Germany. We assessed the current state of pain management in German hospitals. METHODS: From 2004 to 2006, data were obtained anonymously from 2252 patients who had undergone surgery, and 999 who had been treated non-surgically, in a total of 25 hospitals. They were interviewed about the intensity of pain they had experienced and about the effectiveness of its treatment. RESULTS: No pain at all was reported by 12.4% of patients who had undergone surgery and by 16.7% of the non-surgically treated patients. Moderate to severe pain at rest was reported by 29.5% of the surgical group and 36.8% of the non-surgical group. More than 50% of the overall group reported pain on movement. 55% of the surgical group, and 57% of the non-surgical group, were dissatisfied with their pain management. Peak pain tended to occur outside normal working hours. No analgesic treatment at all was given to 39% of patients in the non-surgical group, even though they were in pain; the corresponding figure for the surgical group was 15% (a significant difference, p<0.001). Inadequately effective pain management was reported by 45.6% of patients in the non-surgical group and 29.6% in the operative group (again, a significant difference. Cancer patients were treated more often with potent opioids. CONCLUSION: Severe postoperative pain is still too common among hospitalized patients, particularly pain that is induced by movement. Patients being treated on non-surgical wards also often suffer severe pain needlessly. Pain management seems to be worse for non-surgical patients (cancer patients excepted) than for surgical patients: waiting times for medication are longer, and ineffective medications are given more often. On the other hand, a number of hospitals provide positive examples of the potential effectiveness of pain management for both surgical and non-surgical patients.

Laryngeal mask airway or endotracheal tube for percutaneous dilatational tracheostomy: a comparison of visibility of intratracheal structures.

PURPOSE: Some severe complications during percutaneous dilatational tracheostomy (PDT) may be related to poor visualization of tracheal structures. Subjectively, the bronchoscopical view obtained via a laryngeal mask airway (LMA) seems to be better than that obtained with an endotracheal tube (ETT). In this prospective, randomized study, we compared LMA and ETT as the ventilatory device during PDT mainly with respect to visualization of tracheal structures. The quality of ventilation and airway-related complications are also reported. METHODS: In this prospective, randomized study, PDT was performed using an LMA (n = 33) or an ETT (n = 30). Quality of ventilation and visualization of tracheal structures (thyroid, cricoid, and tracheal cartilages) were rated as follows: very good (1), good (2), difficult (3), and not possible (4) with LMA/ETT. A rating of 4 required the alternate airway. Groups were compared using the chi(2) test. RESULTS: Visualization of tracheal structures was better with the LMA: ratings were 1 or 2 in 94% of patients with an LMA, compared with 66% of patients with an ETT (P <0.05). Visual control during puncturing the trachea was 1 or 2 in 97% of patients using an LMA and 77% of patients for an ETT (P < 0.05). A rating of 4 was assigned to 1 patient with an LMA and to 3 patients with an ETT. Hemodynamic variables were similar in both groups. Blood gas analysis during PDT showed decreased Pao(2) in both groups, and increased Paco(2), which was more pronounced with an ETT compared with an LMA (59 +/- 14 mm Hg and 51 +/- 11 mm Hg [P < 0.05]). In the ETT group, 2 patients were extubated accidentally, and in another patient, the bronchoscope was damaged because of insufficient visualization of the tracheal puncture site. CONCLUSION: The LMA technique showed definite advantages regarding visualization of relevant tracheal structures and the dilation process compared with an ETT. This may be especially relevant in the hands of inexperienced intensivists and in cases of difficult patient anatomy where improved structural visualization optimizes operating conditions.

Chronic pain in primary care. German figures from 1991 and 2006.

BACKGROUND: Until now only limited research has been done on the prevalence of chronic pain in primary care. The aim of this investigation was to study the health care utilisation of patients suffering from pain. How many patients visit an outpatient clinic because of the symptom of pain? These data were compared with data from a similar study in 1991, to investigate whether improvements had been achieved. METHODS: A total of 1201 consecutive patients visiting outpatient clinics were surveyed in six practices in the western part of Germany on randomly selected days by means of questionnaires. Topics were the point prevalence of pain and the period prevalence of chronic pain, its characteristics and its impact on daily life, as well as data on previous therapies for pain. A retrospective comparison was made with the data from a similar study with same design surveying 900 patients that took place in five practices during 1991. RESULTS: In 2006, pain was the main reason for consulting a doctor in 42.5% of all patients (1991: 50.3%). Of all respondents, 62% suffered from pain on the particular day of the consultation, and 40% reported that they had been suffering from pain for more than six months (1991: 36.4%). As many as 88.3% of patients with chronic pain reported a negative impact on their daily life due to this pain (1991: 68%), and 88.1% reported impairment of their working life because of chronic pain (1991: 59.1%). CONCLUSION: Pain, and chronic pain in particular, is a central problem in primary care. Over the last 15 years, the number of patients suffering from chronic pain has not decreased. In nearly half of all cases, pain is still the reason for health care utilisation in outpatient clinics. Pain represents a major primary health care problem with enormous impact on public health. Improvements can only be achieved by improving the quality of health care at the primary care level.

[Therapy of phantom limb pain]. / Phantomschmerzen--Pathomechanismen und Therapieansätze.

About 80 % of all extremity amputations suffer from phantom limb pain following the operation. In this context, it is important to differentiate between painful phantom limb sensations, non-painful phantom limb sensations and residual limb pain. The pathophysiology of phantom limb pain is not fully understood. Current research findings ascribe a major pathophysiological role to cortical changes as well as a disturbed body perception. Peripheral and spinal mechanisms appear less relevant in the development of phantom limb pain. An essential part of the therapy is the pharmacological treatment with antidepressants, anticonvulsives and opioids. Another significant aspect of therapy is senso-motory training, important to mention here would be mirror therapy, lateralisation and motor imaging. In case of an elective amputation, an epidural or axiliar plexus catheter should be considered prior to the amputation. The perioperative treatment with ketamine is debated.

Meeting the challenges of opioid-induced constipation in chronic pain management - a novel approach.

Opioid analgesics are the cornerstone of pain management for moderate-to-severe cancer pain and, increasingly, chronic noncancer pain. Despite proven analgesic efficacy, the use of opioids is commonly associated with frequently dose-limiting constipation that seriously impacts on patients' quality of life. Agents currently used to manage opioid-induced constipation (OIC), such as laxatives, do not address the underlying opioid receptor-mediated cause of constipation and are often ineffective. A significant need therefore exists for more effective treatment options. A novel approach for selectively and locally antagonizing the gastrointestinal effects of opioids involves the coadministration of a mu-opioid receptor antagonist with negligible systemic availability, such as oral naloxone. Combination therapy with prolonged-release (PR) oxycodone plus PR naloxone has been shown to provide effective analgesia while preventing or reducing constipation. The current article highlights this novel strategy in its potential to significantly improve the quality of life of patients suffering from chronic pain, affording patients the benefit of full analgesia, without the burden of OIC.

Redefining (somatoform) pain disorder in ICD-10: a compromise of different interest groups in Germany.

PURPOSE OF REVIEW: Pain is one of the most frequent reasons to visit health professionals. Many patients suffering from chronic pain conditions not only need medical treatment but also psychiatric or psychological interventions. This additional treatment need should be underlined using an ICD section F diagnosis. The current ICD-10 diagnosis of somatoform pain disorder requests psychological causation of the pain, which is frequently unclear or difficult to decide. RECENT FINDINGS: In Germany, the different interest groups, namely of psychiatry, pain research, psychosomatic medicine and clinical psychology, met to find a consensus on how to re-classify pain disorder under section F of ICD-10. This manuscript summarizes the result. SUMMARY: A diagnosis of pain disorder is necessary to underline the additional need of psychiatric/psychological interventions in chronic pain conditions. This diagnosis should include psychological features that are relevant for development or maintenance of chronic pain. In contrast to earlier attempts of redefining pain diagnoses, our attempt included representatives of the association for the study of pain.